Moderna COVID-19 Vaccine
Proper Name
COVID-19 mRNA Vaccine (nucleoside modified)
Indication
COVID-19 Vaccine Moderna is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The use of this vaccine should be in accordance with official recommendations.
Description

Single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.

Manufacturing Platform

PARAMETER

DATA

Manufacturer

ModernaTX, Inc

Transgene

-

Indication

COVID-19 Vaccine Moderna is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The use of this vaccine should be in accordance with official recommendations.

Virus and Serotype

mRNA

Cell Substrate

-

Manufacturing platform

The uncapped mRNA is transcribed from linear DNA utilizing an in vitro transcription (IVT) reaction followed by purification and filtration steps. Next, mRNA is enzymatically capped followed by additional purification and filtration steps. Finally, CX-214414 mRNA is filtered, dispensed and stored.

Dose in vial/final container

Each vial contains sufficient volume to extract 10 doses of 0.5 mL each. One dose (0.5 mL) contains 100 micrograms of messenger RNA (mRNA) (embedded in SM-102 lipid nanoparticles).

Dose / patient

Two 0.5 mL doses. Second dose administered 28 days after the first dose

Clinical Trials:

NCT

TRIAL PHASE

SUBJECTS ENROLLED

TITLE

COUNTRIES

NCT04405076

2

600

Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older

United States

NCT04470427

3

30000

A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19

United States

NCT04649151

2, 3

3000

A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19 (TeenCove)

United States
Key Regulatory Milestones

11/30/2020 - ModernaTX  submitted an Emergency Use Authorization (EUA) request to FDA for an investigational COVID-19 vaccine.

12/18/2020 - FDA issued EUA for the vaccine

01/06/2021 - European EUA approval date

Advisory Committee

A meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) was convened on December 17, 2020. Following a discussion of the data presented, the VRBPAC voted 20-1 (with 1 abstention) in favor of the determination that based on the totality of scientific evidence available, the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older. The review team therefore recommends issuance of an EUA for use of the Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

Package Insert
COVID-19 Vaccine Moderna: EPAR - Product information
Advanced Facts
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